Parkinson's Disease Clinical Trial
Official title:
The Clinical and Neuroimaging Differences Between Patients With Vascular Parkinsonism and Idiopathic Parkinson's Disease
NCT number | NCT04308135 |
Other study ID # | MD209/2019 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | September 1, 2019 |
Est. completion date | April 1, 2022 |
Verified date | September 2023 |
Source | Ain Shams University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Vascular parkinsonism (VP) is defined as the presence of parkinsonian syndrome, evidence of cerebrovascular disease by brain imaging and an established relationship between the two disorders. However, the diagnosis of VP is problematic. This study aims to distinguish VP from Parkinson's disease (PD) in multiple aspects including clinical features as motor ,non motor symptoms ,response to treatment ,cognitive assessments by using multiple scales, neuro-radiological features of magnetic resonance imaging (MRI) and transcranial color-coded duplex (TCCD) findings. This differentiation will have therapeutic and prognostic implications .
Status | Completed |
Enrollment | 104 |
Est. completion date | April 1, 2022 |
Est. primary completion date | December 1, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 40 Years and older |
Eligibility | Inclusion Criteria: - Patients diagnosed with PD or VP, and healthy controls will be included in the study. - PD diagnosis will be based on the Queen Square Brain Bank for Neurological Disorders clinical criteria and MDS criteria. - The VP patients will be included if they fulfill the following criteria (Zijlman's diagnostic criteria)Parkinsonism presentation (at least two of the cardinal features: tremors, bradykinesia, rigidity and postural instability). Cerebrovascular disease, defined as evidence of relevant cerebrovascular disease by brain imaging or the presence of focal signs or symptoms consistent with stroke. A relationship between (1) and (2): acute or delayed progressive onset of parkinsonism. Based on the above criteria, two forms of VP are suggested: one with acute onset, and another one with insidious progression. The diagnosis will be confirmed by assigning a vascular score. Two points or more are essential to diagnose VP. The points will be assigned as follows: - Two points: Pathologically or angiographically proven diffuse vascular disease. - One point: Onset of parkinsonism within 1 month of clinical stroke. - One point: History of two or more strokes. - One point: Neuroimaging evidence of vascular disease in two or more vascular territories. - One point: History of two or more risk factors for stroke (hypertension, smoking, diabetes mellitus, hyperlipidaemia, presence of heart disease associated with stroke [coronary artery disease, atrial fibrillation, congestive heart failure, valvular heart disease, mitral valve prolapse, and other arrhythmias], family history of stroke, history of gout, and peripheral vascular disease) Exclusion Criteria: - PD patients with age at onset less than 40 years. - Any alternative cause that significantly impair gait. - Inability of the patient to undergo neuroimaging. - Patients couldn't perform the test or severely demented. - Atypical and other secondary parkinsonism as patients who had a history of toxin exposure.or antipsychotic drugs treatment by history ,neurological examination and brain MRI . - Family or patient's refusal to give written consent. |
Country | Name | City | State |
---|---|---|---|
Egypt | Ain Shams University | Cairo |
Lead Sponsor | Collaborator |
---|---|
Ain Shams University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | MDS-UPDRS scale on on and off state | It detects the motor differences between Vascular Parkinsonism and Parkinson's Disease by scores on the scale ...the maxium score is 199 represents the worst (total disability) with a score of zero representing (no disability) | 2 year... will be at single point | |
Primary | Montreal Cognitive Assessment (MoCA) (Arabic version) | MoCA scores range between 0 and 30. .high score more than or equal 26 is normal | 2 years....will be at single point | |
Primary | White matter severity by MRI brain | White matter differences by fazekas scale 0,1,2 or 3 scores | 2 years....will be at single point | |
Primary | Non motor symptoms scale | It detects the non motor symptoms differences between Vascular Parkinsonism and Parkinson's Disease byUsing a distribution of NMSS scores by quartiles, a classification based on levels from 0 (no NMS at all) to 4 (very severe NMS) for 30 itemes ...high score is worst | 2 years.....will be at single point | |
Primary | Addenbrooke's test (Arabic version) | for aassement of Visuospatial skills, Language and verbal fluency result score 16 for visuospatial processing ,26 for language 14 for fluency high score is best | 2 year ....will be at single point | |
Primary | Wechsler Adult Intelligence Scale (WAIS) | The average score for the test is 100, and any score from 90 to 109 is considered to be in the average intelligence range. Score from 110 to 119 are considered to be High Average. Superior scores range from 120 to 129 and anything over 130 is considered Very Superior. | 2 year....will be at single point | |
Primary | Frontal Assessment Battery scale. | Frontal Assessment Battery scale..total score is from a maximum of 18, higher scores indicating better performance. | 2 year ....will be at single point | |
Secondary | Substantia nigra Echogenicity by transcranial doppler | to detect differences of substantia nigra Echogenicity by millimeter and differences of mean flow velocities by centimeter per second | 2 years | |
Secondary | Carotid arties wall thickness by Extra cranial duplex | to detect differences of Intima-media thickness values by millimeter and flow velocities by centimeter per second | 2 year |
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